A pilot randomized controlled trial of a tailored cognitive behavioural therapy based intervention for depressive symptoms in those newly diagnosed with multiple sclerosis.

Litza A Kiropoulos,Jennifer Threader,Trevor Kilpatrick,Alex Holmes

doi:10.1186/s12888-016-1152-7

Abstract

BackgroundTo examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis.MethodsThe current study presents a pilot, parallel group randomized controlled trial (RCT) with an allocation ratio of 1:1 conducted in a large research and teaching hospital in Melbourne, Australia. 30 individuals with a mean age of 36.93 years (SD = 9.63) who were newly diagnosed with multiple sclerosis (MS) (X = 24.87 months, SD = 15.61) were randomized to the CBT intervention (n = 15) or treatment as usual (TAU) (n = 15). The primary outcome was level of depressive symptoms using the Beck Depression Inventory-II (BDI-II). Secondary outcomes were level of anxiety, fatigue and pain impact, sleep quality, coping, acceptance of MS illness, MS related quality of life, social support, and resilience. Tertiary outcomes were acceptability and adherence to the intervention.ResultsLarge between group treatment effects were found for level of depressive symptoms at post and at 20 weeks follow-up (d = 1.66–1.34). There were also small to large group treatment effects for level of anxiety, fatigue and pain impact, sleep quality, MS related quality of life, resilience, and social support at post and at 20 weeks follow-up (d = 0.17–1.63). There were no drop-outs and participants completed all treatment modules. All participants reported the treatment as ‘very useful’, and most (73.4%) reported that the intervention had addressed their problems ‘completely’.ConclusionsThese data suggest that the tailored early intervention is appropriate and clinically effective for the treatment of depressive symptoms in those newly diagnosed with MS. A larger RCT comparing the CBT intervention with an active comparative treatment with longer term follow-up and cost effectiveness analyses is warranted. The pilot trial has been retrospectively registered on 28/04/2016 with the ISRCTN registry (trial ID ISRCTN10423371).

Highlights

To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis
Half of the participants have been previously diagnosed with depression and almost half have previously been diagnosed with an anxiety disorder
This study demonstrated that a tailored 8-week individual face-to-face CBT based intervention was effective in significantly reducing depressive symptoms in patients newly diagnosed with Multiple sclerosis (MS)

Summary

Introduction

To examine the effectiveness and acceptability of an 8-week individual tailored cognitive behavioural therapy (CBT) intervention for the treatment of depressive symptoms in those newly diagnosed with multiple sclerosis. Depression and anxiety have been found to be common in individuals with MS and have been reported to be at clinically high levels especially in the early stages of the illness [2,3,4]. Anxiety affects between 16 and 45% of the MS population [7, 8] and has been associated with younger age of onset, disease severity, fatigue [9] and severity of depressive symptoms [10]. Two studies suggest that up to 36% of MS patients continue to have high levels of depressive and anxiety symptoms in the first years after diagnosis [3, 11]

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